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Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

National Institutes of Health

This Funding Opportunity Announcement (FOA) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015 ). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website .

This FOA will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increasing community engagement, reducing health inequties and disparities, and include a Plan for Increasing Diverse Perspectives (PDEP).

Deadlines:

Letter of Intent Due Date(s): 30 days prior to the application due date
New Applications: October 11, 2022; Feb 10, 2023; June 13, 2023; Oct 11, 2023; Feb 13, 2024; June 11, 2024; Oct 11, 2024; Feb 11, 2025; June 11, 2025
Renewal / Resubmission / Revision Applications: Nov 10, 2022; March 10, 2023; July 11, 2023; Nov 13, 2023; March 11, 2024; July 11, 2024; Nov 11, 2024; March 11, 2025; July 11, 2025
AIDS Applications: January 11, 2023; May 11, 2023; Sep 11, 2023; Jan 11, 2024, May 10, 2024; Sep 11, 2024; Jan 11, 2025; May 11, 2025; Sep 11, 2025

PAR-22-189 Expiration Date September 12, 2025

Specialties

Medical

Medical - Clinical Science

Eligibility Requirements

ESI applicants can be the PI/PD of an application providing they can show support of investigators with appropriate clinical trials experience .ESIs are encouraged to be part of thestudyteamandthey should bebudgeted forsupportat a level appropriate for the role on the project.